L’FDA ha aggiunto in data 18 ottobre 2018, La MENINGITE come effetto collaterale del VACCINO VARIVAX ( VARICELLA SINGOLO ) a seguito delle segnalazioni di reazioni avverse post marketing.
We have approved your request dated April 20, 2018, to supplement your Biologics
License Application (BLA) submitted under section 351(a) of the Public Health Service
Act (42 U.S.C. 262) for Varicella Virus Vaccine Live (VARIVAX) manufactured at your
West Point, Pennsylvania facilities to revise the package insert to include the term “meningitis” in Section 6.2 Post-Marketing Experience and to clarify previously reported terms of “encephalitis” and “herpes zoster.”
6.2 Post-Marketing Experience